FDA: Herbal supplement may have opioid effect

Sunday, 11 Feb, 2018

The popular botanical drug kratom essentially is an opioid, the U.S. Food and Drug Administration declared Tuesday. Advocates of kratom have long said that the plant-derived substance can be safer than opioid drugs sold at a pharmacy or on the street, fighting pain and treating symptoms of opioid withdrawal without the same, potentially deadly effects on respiration.

"Claiming that kratom is benign because it's "just a plant" is shortsighted and unsafe", Gottlieb said in a statement. As part of an agency statement on kratom, FDA shared recent data on deaths and other serious adverse effects involving the improper use of this supplement. This naturally growing herbal substance native to several parts of Asia, has recently entered the United States market illegally under claims of being able to treat chronic pain symptoms and other conditions.

"Importantly, as commonly used in raw plant form, it does not appear to produce the highly addictive euphoria or lethal respiratory depressing effects of classical opioids", the group, including scientists from Johns Hopkins University, Columbia University and the University of Rochester, wrote.

Gottlieb, in a November public health advisory and again on Wednesday (NZ time), said there are no FDA-approved uses for kratom.

The FDA's research reports Kratom has been linked to 44 deaths. Kratom proponents have said the government sometimes blames kratom for deaths caused by other substances, but the new fatality cited by the FDA, given the absence of other substances, "reinforces our concerns", Gottlieb said. In 2016, the DEA announced plans to place kratom temporarily in Schedule 1 of the Controlled Substances Act, a category for drugs such as heroin. But officials backtracked after a public outcry and pressure from some members of Congress. FDA has stepped in, concerned over the product's lack of scientific evidence to support medical claims.

The FDA provided that evaluation late previous year. Further analysis confirmed that two of the most prevalent compounds in kratom are known to activate opioid receptors, and that kratom has a strong bind to mu opioid receptors, comparable to those of scheduled opioid drugs.

Henningfield, who has done work for the nonprofit American Kratom Association, argued late a year ago that the substance's "overall abuse potential and risk of death isn't anything close to narcotics like opioids", and warned that restricting or banning it could drive some people onto the black market to buy it or push them back to opioids.

"They are claiming that 44 people died from a range of causes-including just being completely unexplainable-while also using kratom", said American Kratom Association chairman Dave Herman in a statement.

"I don't really see what this adds to this field or adds to the body of knowledge around kratom", Andrew Kruegel, a Columbia University pharmacologist who has extensively studied kratom and signed the letter, told Tonic.